FAIR-HF
Trial question
What is the role of intravenous ferric carboxymaltose in patients with chronic HF and iron deficiency?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 459
459 patients (244 female, 215 male).
Inclusion criteria: patients with chronic HF, reduced LVEF, and iron deficiency, with or without anemia.
Key exclusion criteria: uncontrolled hypertension, other clinically significant heart disease, inflammation, or clinically significantly impaired liver or renal function.
Interventions
N=304 ferric carboxymaltose (200 mg of intravenous iron weekly).
N=155 placebo (intravenous saline weekly).
Primary outcome
Percentage of patients achieving good or moderate improvement on self-reported Patient Global Assessment at 24 weeks
50%
28%
50.0 %
37.5 %
25.0 %
12.5 %
0.0 %
Ferric
carboxymaltose
Placebo
Significant
increase ▲
NNT = 4
Significant increase in the percentage of patients achieving good or moderate improvement on the self-reported Patient Global Assessment at 24 weeks (50% vs. 28%; OR 2.51, 95% CI 1.75 to 3.61).
Secondary outcomes
Significant increase in NYHA functional class I or II at 24 weeks (47% vs. 30%; OR 2.4, 95% CI 1.55 to 3.71).
Safety outcomes
No significant differences in rates of death, adverse events, and serious adverse events.
Conclusion
In patients with chronic HF, reduced LVEF, and iron deficiency, with or without anemia, ferric carboxymaltose was superior to placebo with respect to the percentage of patients achieving good or moderate improvement on the self-reported Patient Global Assessment at 24 weeks.
Reference
Anker SD, Comin Colet J, Filippatos G et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48.
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